Associate Director, ECP Regulatory - Development Sciences

☞ Biogen

View: 103

Update day: 11-06-2024

Location: Maidenhead South East

Category: Other

Industry: Biotechnology Pharmaceuticals Research

Position: Director

Job type: Full-time

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Job content

Job Description

About this role

Joining us as Associate Director within Development Sciences, you will be responsible for the Europe, Canada and Partner Market (ECP) regional development strategy, in alignment with the ECP business strategy.

You will be responsible for defining and implementing ECP regional regulatory strategies, including filing of regulatory submissions for assigned programs. In addition, you will be responsible for leading and/or oversight of the planning, coordination and preparation of regulatory submissions. The Associate Director will identify and assess regulatory risks associated with product development and define strategies to mitigate risks. You will direct the organization and preparation of clear and effective submissions and secure alignment across functions.

What You’ll Do
  • Responsible for defining/developing and implementing innovative regional regulatory strategies, including filing of all appropriate regulatory submissions e.g. MAAs, PIPs, ODDs. Lead health authority meetings (Scientific advice, PIP clarification, Rapporteur meetings, Pre-submission, oral explanation, SAG etc.).
  • Identify and assess regulatory risks associated with assigned projects and overall product development. Defining strategies to mitigate risks.
  • Provide leadership on project teams and subcommittees in all areas of regulatory science. Provide input to Regulatory Senior Management teams and regulatory guidance to company personnel.
  • Influence key stakeholders in multiple departments at all levels. Interact with a wide variety of outside contacts (including consultants/ contractors, corporate partners and regulatory agency personnel).
  • Autonomously represent the company with local and regional regulatory authorities, contractors and corporate partners.

Qualifications
  • BA/BS/University degree required, Life/Health Sciences preferred
  • A strong background in the Pharmaceutical/Biotechnology industry within Regulatory Sciences, with technical management experience.
  • EU regulatory experience managing development programs, preferred.
  • Experience in interpretation of regulations, guidelines and policy statements.
  • Experience and knowledge in the preparation of regulatory submissions and involvement in regulatory authority meetings.

Additional Information

The Ideal Candidate Will Embody The Following Attributes
  • Agility: Ability to adapt to change and make timely decisions to enable agile execution
  • Accountable: Comfortable working independently, a self-starter
  • Customer Focused: Commitment to a customer-first culture and motivation to solving complex problems
  • Inclusive: High emotional intelligence in leading teams to success
  • Pioneering: Innovative and willing to take risks
  • Ethical: upholds high standards for performance and integrity
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Deadline: 26-07-2024

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